ID

39335

Description

Trial of Diet in Gestational Diabetes Mellitus: Metabolic Consequences to Mother and Offspring; ODM derived from: https://clinicaltrials.gov/show/NCT02244814

Link

https://clinicaltrials.gov/show/NCT02244814

Keywords

Versions (1)
  1. 12/21/19 12/21/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 21, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Gestational Diabetes Mellitus NCT02244814

English

Eligibility Gestational Diabetes Mellitus NCT02244814

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pregnant women will be between the ages of 20-36 yrs
Description

Pregnancy | Age

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0001779
bmi of 26-39 kg/m2 at the time of diagnosis
Description

Body mass index

Data type

boolean

Alias
UMLS CUI [1]
C1305855
singleton pregnancy
Description

Single pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0341899
no oral hypoglycemic therapy before entering the study
Description

Oral hypoglycemic Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0359086
UMLS CUI [1,2]
C0332197
diagnosed with gestational diabetes according to the criteria established by the american college of obstetricians and gynecologists, specifically, they will have 2 abnormal values on a 100-g 3 hr glucose tolerance test 205, 206: fasting>95 mg/dl but <105 mg/dl; 1hr> 180 mg/dl; 2 hr>155 mg/dl; 3 hr>140 mg/dl.
Description

Gestational Diabetes | Abnormal glucose tolerance test | Fasting glucose measurement Hour Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0085207
UMLS CUI [2]
C0159069
UMLS CUI [3,1]
C0202045
UMLS CUI [3,2]
C0439227
UMLS CUI [3,3]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
extreme hypertriglyceridemia
Description

Hypertriglyceridemia Extreme

Data type

boolean

Alias
UMLS CUI [1,1]
C0020557
UMLS CUI [1,2]
C0205403
overt diabetes
Description

Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C0011849
suspected preexisting diabetes (a1c≥6.5%, fasting glucose>125 mg/dl, or random glucose >200/mg/dl)
Description

Diabetes Mellitus Pre-existing Suspected | Hemoglobin A1c measurement | Glucose measurement, fasting | Glucose measurement, random

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0750491
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0202045
UMLS CUI [4]
C0202046
women highly likely to fail diet by any of the following criteria will be excluded:1) fasting glucose >105 mg/dl, due to the higher likelihood of failing diet and requiring medical treatment 139; 2) fasting triglyceride > 400 mg/dl.
Description

Gender | Diet therapy fails Probably | Glucose measurement, fasting | Serum fasting triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0012159
UMLS CUI [2,2]
C0231175
UMLS CUI [2,3]
C0750492
UMLS CUI [3]
C0202045
UMLS CUI [4]
C0582824
non-english speaking
Description

Lacking Able to speak English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C0564215
UMLS CUI [1,3]
C0376245
smokers (leading cause of low birth weight)
Description

Tobacco use

Data type

boolean

Alias
UMLS CUI [1]
C0543414
risk factors for placental insufficiency (hypertension, renal disease, thrombophilias, rheumatologic disease, preeclampsia, steroid use, history of pancreatitis, infectious disease, or intrauterine growth restriction)
Description

Risk factors Placental Insufficiency | Hypertensive disease | Kidney Diseases | Thrombophilia | Rheumatic disorder | Pre-Eclampsia | Steroid use | Pancreatitis | Communicable Diseases | Fetal Growth Retardation

Data type

boolean

Alias
UMLS CUI [1,1]
C0035648
UMLS CUI [1,2]
C0032051
UMLS CUI [2]
C0020538
UMLS CUI [3]
C0022658
UMLS CUI [4]
C0398623
UMLS CUI [5]
C3495832
UMLS CUI [6]
C0032914
UMLS CUI [7]
C0281991
UMLS CUI [8]
C0030305
UMLS CUI [9]
C0009450
UMLS CUI [10]
C0015934
history of pancreatitis
Description

Pancreatitis

Data type

boolean

Alias
UMLS CUI [1]
C0030305
history of pre-term labor
Description

Preterm Labor

Data type

boolean

Alias
UMLS CUI [1]
C0022876
taking beta blockers/glucocorticoids
Description

Adrenergic beta-1 Receptor Antagonists | Glucocorticoids

Data type

boolean

Alias
UMLS CUI [1]
C0304516
UMLS CUI [2]
C0017710
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Similar models

Eligibility Gestational Diabetes Mellitus NCT02244814

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Pregnancy | Age
Item
pregnant women will be between the ages of 20-36 yrs
boolean
C0032961 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body mass index
Item
bmi of 26-39 kg/m2 at the time of diagnosis
boolean
C1305855 (UMLS CUI [1])
Single pregnancy
Item
singleton pregnancy
boolean
C0341899 (UMLS CUI [1])
Oral hypoglycemic Absent
Item
no oral hypoglycemic therapy before entering the study
boolean
C0359086 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Gestational Diabetes | Abnormal glucose tolerance test | Fasting glucose measurement Hour Quantity
Item
diagnosed with gestational diabetes according to the criteria established by the american college of obstetricians and gynecologists, specifically, they will have 2 abnormal values on a 100-g 3 hr glucose tolerance test 205, 206: fasting>95 mg/dl but <105 mg/dl; 1hr> 180 mg/dl; 2 hr>155 mg/dl; 3 hr>140 mg/dl.
boolean
C0085207 (UMLS CUI [1])
C0159069 (UMLS CUI [2])
C0202045 (UMLS CUI [3,1])
C0439227 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Hypertriglyceridemia Extreme
Item
extreme hypertriglyceridemia
boolean
C0020557 (UMLS CUI [1,1])
C0205403 (UMLS CUI [1,2])
Diabetes Mellitus
Item
overt diabetes
boolean
C0011849 (UMLS CUI [1])
Diabetes Mellitus Pre-existing Suspected | Hemoglobin A1c measurement | Glucose measurement, fasting | Glucose measurement, random
Item
suspected preexisting diabetes (a1c≥6.5%, fasting glucose>125 mg/dl, or random glucose >200/mg/dl)
boolean
C0011849 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0750491 (UMLS CUI [1,3])
C0474680 (UMLS CUI [2])
C0202045 (UMLS CUI [3])
C0202046 (UMLS CUI [4])
Gender | Diet therapy fails Probably | Glucose measurement, fasting | Serum fasting triglyceride measurement
Item
women highly likely to fail diet by any of the following criteria will be excluded:1) fasting glucose >105 mg/dl, due to the higher likelihood of failing diet and requiring medical treatment 139; 2) fasting triglyceride > 400 mg/dl.
boolean
C0079399 (UMLS CUI [1])
C0012159 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0750492 (UMLS CUI [2,3])
C0202045 (UMLS CUI [3])
C0582824 (UMLS CUI [4])
Lacking Able to speak English Language
Item
non-english speaking
boolean
C0332268 (UMLS CUI [1,1])
C0564215 (UMLS CUI [1,2])
C0376245 (UMLS CUI [1,3])
Tobacco use
Item
smokers (leading cause of low birth weight)
boolean
C0543414 (UMLS CUI [1])
Risk factors Placental Insufficiency | Hypertensive disease | Kidney Diseases | Thrombophilia | Rheumatic disorder | Pre-Eclampsia | Steroid use | Pancreatitis | Communicable Diseases | Fetal Growth Retardation
Item
risk factors for placental insufficiency (hypertension, renal disease, thrombophilias, rheumatologic disease, preeclampsia, steroid use, history of pancreatitis, infectious disease, or intrauterine growth restriction)
boolean
C0035648 (UMLS CUI [1,1])
C0032051 (UMLS CUI [1,2])
C0020538 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0398623 (UMLS CUI [4])
C3495832 (UMLS CUI [5])
C0032914 (UMLS CUI [6])
C0281991 (UMLS CUI [7])
C0030305 (UMLS CUI [8])
C0009450 (UMLS CUI [9])
C0015934 (UMLS CUI [10])
Pancreatitis
Item
history of pancreatitis
boolean
C0030305 (UMLS CUI [1])
Preterm Labor
Item
history of pre-term labor
boolean
C0022876 (UMLS CUI [1])
Adrenergic beta-1 Receptor Antagonists | Glucocorticoids
Item
taking beta blockers/glucocorticoids
boolean
C0304516 (UMLS CUI [1])
C0017710 (UMLS CUI [2])
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